BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR

    K Number: K970211 · Decision Apr 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    3
    Review Days
    464

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    Basic Information

    Device Name
    MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR
    K Number
    K970211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Weiss Electronics
    Date Received
    January 21, 1997
    Decision Date
    April 30, 1998
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Micro Weiss Electronics

    K Number Device Name
    K970139 MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO
    K972259 PRO CHECK DIGITAL PACIFIER THERMOMETER